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Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238420
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : May 23, 2016
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bladder Urothelial Carcinoma
Stage I Bladder Cancer AJCC v6 and v7
Stage II Bladder Cancer AJCC v6 and v7
Stage III Bladder Cancer AJCC v6 and v7
Interventions Drug: Paclitaxel
Radiation: Radiation Therapy
Biological: Trastuzumab
Enrollment 70
Recruitment Details  
Pre-assignment Details After patient registration, sites submitted tissue to central her2/neu evaluation. If tissue was evaluable and a patient continued on study, then treatment arm was assigned. Seventy-six patients were registered and 6 did not continue to treatment assignment: 2 patient withdrawal, 2 protocol violation, 1 progressive disease, 1 institutional error.
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy Paclitaxel chemotherapy concurrent with radiation therapy
Period Title: Overall Study
Started 22 48
Completed 21 [1] 47 [1]
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             1
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel Total
Hide Arm/Group Description Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy Paclitaxel chemotherapy concurrent with radiation therapy Total of all reporting groups
Overall Number of Baseline Participants 21 47 68
Hide Baseline Analysis Population Description
Eligible patients who started protocol treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 47 participants 68 participants
80
(51 to 86)
73
(53 to 90)
75
(51 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 47 participants 68 participants
Female
2
   9.5%
11
  23.4%
13
  19.1%
Male
19
  90.5%
36
  76.6%
55
  80.9%
1.Primary Outcome
Title Acute Treatment-related Toxicity
Hide Description In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.
Time Frame From start of protocol treatment to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description:
Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
Paclitaxel chemotherapy concurrent with radiation therapy
Overall Number of Participants Analyzed 21 47
Measure Type: Number
Unit of Measure: participants
7 14
2.Secondary Outcome
Title Treatment Completion
Hide Description The number of patients within each group who completed all elements of protocol treatment are reported.
Time Frame From registration to end of treatment; up to 64 days."
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description:
Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
Paclitaxel chemotherapy concurrent with radiation therapy
Overall Number of Participants Analyzed 21 47
Measure Type: Number
Unit of Measure: participants
13 34
3.Secondary Outcome
Title Complete Response to Treatment
Hide Description The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.
Time Frame At 12 weeks from treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment and had an evaluation to assess response by 12 weeks
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description:
Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
Paclitaxel chemotherapy concurrent with radiation therapy
Overall Number of Participants Analyzed 13 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.5
(31.6 to 86.1)
57.6
(39.2 to 74.5)
4.Secondary Outcome
Title Progression-free Survival
Hide Description Disease (failure) is defined as any bladder cancer progression determined by all measures of disease including physical exam, imaging, and biopsies. Disease-free survival time is defined as time from treatment start to the date of first progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared.
Time Frame From start of treatment to last follow-up. Maximum follow-up at time of analysis was 9.9 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who started treatment. (This population changed since the initial analysis: 3 participants first thought to be eligible were later determined to be ineligible.)
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description:
Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
Paclitaxel chemotherapy concurrent with radiation therapy
Overall Number of Participants Analyzed 20 45
Median (95% Confidence Interval)
Unit of Measure: years
1.1
(0.6 to 2.8)
0.8
(0.4 to 3.0)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as time from treatment start to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared.
Time Frame From the date of treatment started to death, assessed up to at least 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who started treatment. (This population changed since the initial analysis: 3 participants first thought to be eligible were later determined to be ineligible.)
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description:
Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
Paclitaxel chemotherapy concurrent with radiation therapy
Overall Number of Participants Analyzed 20 45
Median (95% Confidence Interval)
Unit of Measure: years
2.8
(1.1 to 4.4)
2.0
(1.1 to 8.5)
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
 
Arm/Group Title HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Hide Arm/Group Description Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy Paclitaxel chemotherapy concurrent with radiation therapy
All-Cause Mortality
HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   6/21 (28.57%)   15/47 (31.91%) 
Blood and lymphatic system disorders     
Hemoglobin * 1  0/21 (0.00%)  1/47 (2.13%) 
Cardiac disorders     
Myocardial ischemia * 1  0/21 (0.00%)  1/47 (2.13%) 
Sinus bradycardia * 1  0/21 (0.00%)  1/47 (2.13%) 
Supraventricular arrhythmia NOS * 1  1/21 (4.76%)  0/47 (0.00%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
Colonic perforation * 1  1/21 (4.76%)  0/47 (0.00%) 
Diarrhea NOS * 1  4/21 (19.05%)  3/47 (6.38%) 
Enteritis * 1  0/21 (0.00%)  1/47 (2.13%) 
Proctitis NOS * 1  1/21 (4.76%)  0/47 (0.00%) 
Vomiting NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
General disorders     
Edema: limb * 1  1/21 (4.76%)  0/47 (0.00%) 
Pyrexia * 1  0/21 (0.00%)  2/47 (4.26%) 
Sudden death * 1  0/21 (0.00%)  1/47 (2.13%) 
Hepatobiliary disorders     
Hepatobiliary/pancreas - Other * 1  0/21 (0.00%)  1/47 (2.13%) 
Infections and infestations     
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Urinary tract NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
Kidney infection NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
Pneumonia NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
Urinary tract infection NOS * 1  1/21 (4.76%)  2/47 (4.26%) 
Injury, poisoning and procedural complications     
Vascular access NOS complication * 1  0/21 (0.00%)  2/47 (4.26%) 
Investigations     
Leukopenia NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
Lymphopenia * 1  1/21 (4.76%)  0/47 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/21 (0.00%)  2/47 (4.26%) 
Hypoalbuminemia * 1  1/21 (4.76%)  0/47 (0.00%) 
Hyponatremia * 1  1/21 (4.76%)  0/47 (0.00%) 
Psychiatric disorders     
Confusional state * 1  0/21 (0.00%)  1/47 (2.13%) 
Personality change * 1  0/21 (0.00%)  1/47 (2.13%) 
Renal and urinary disorders     
Bladder pain * 1  1/21 (4.76%)  0/47 (0.00%) 
Ureteric stenosis * 1  0/21 (0.00%)  1/47 (2.13%) 
Urethral pain * 1  0/21 (0.00%)  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  1/21 (4.76%)  0/47 (0.00%) 
Dyspnea * 1  0/21 (0.00%)  1/47 (2.13%) 
Pneumonitis NOS * 1  0/21 (0.00%)  1/47 (2.13%) 
Vascular disorders     
Hematoma * 1  1/21 (4.76%)  0/47 (0.00%) 
Hypotension NOS * 1  1/21 (4.76%)  0/47 (0.00%) 
Thrombosis * 1  0/21 (0.00%)  1/47 (2.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HER2+ :RT, Paclitaxel, and Trastuzumab HER2- :RT and Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   20/21 (95.24%)   46/47 (97.87%) 
Blood and lymphatic system disorders     
Blood/bone marrow - Other * 1  3/21 (14.29%)  3/47 (6.38%) 
Hemoglobin * 1  15/21 (71.43%)  25/47 (53.19%) 
Cardiac disorders     
Atrial fibrillation * 1  2/21 (9.52%)  1/47 (2.13%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  2/21 (9.52%)  7/47 (14.89%) 
Constipation * 1  4/21 (19.05%)  12/47 (25.53%) 
Diarrhea NOS * 1  12/21 (57.14%)  37/47 (78.72%) 
Flatulence * 1  1/21 (4.76%)  3/47 (6.38%) 
Nausea * 1  5/21 (23.81%)  16/47 (34.04%) 
Proctitis NOS * 1  3/21 (14.29%)  2/47 (4.26%) 
Rectal hemorrhage * 1  2/21 (9.52%)  4/47 (8.51%) 
Stomatitis * 1  0/21 (0.00%)  3/47 (6.38%) 
Vomiting NOS * 1  4/21 (19.05%)  10/47 (21.28%) 
General disorders     
Edema: limb * 1  4/21 (19.05%)  12/47 (25.53%) 
Fatigue * 1  15/21 (71.43%)  39/47 (82.98%) 
Pain - Other * 1  2/21 (9.52%)  2/47 (4.26%) 
Pyrexia * 1  0/21 (0.00%)  4/47 (8.51%) 
Infections and infestations     
Infection with unknown ANC: Urinary tract NOS * 1  2/21 (9.52%)  1/47 (2.13%) 
Opportunisitic infection * 1  2/21 (9.52%)  1/47 (2.13%) 
Urinary tract infection NOS * 1  1/21 (4.76%)  6/47 (12.77%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS * 1  1/21 (4.76%)  7/47 (14.89%) 
Investigations     
Alanine aminotransferase increased * 1  4/21 (19.05%)  1/47 (2.13%) 
Aspartate aminotransferase increased * 1  2/21 (9.52%)  1/47 (2.13%) 
Blood alkaline phosphatase increased * 1  3/21 (14.29%)  2/47 (4.26%) 
Blood bilirubin increased * 1  2/21 (9.52%)  2/47 (4.26%) 
Blood creatinine increased * 1  6/21 (28.57%)  13/47 (27.66%) 
Leukopenia NOS * 1  10/21 (47.62%)  15/47 (31.91%) 
Lymphopenia * 1  8/21 (38.10%)  10/47 (21.28%) 
Metabolic/laboratory - Other * 1  3/21 (14.29%)  1/47 (2.13%) 
Neutrophil count * 1  5/21 (23.81%)  4/47 (8.51%) 
Platelet count decreased * 1  5/21 (23.81%)  10/47 (21.28%) 
Prothrombin time prolonged * 1  2/21 (9.52%)  2/47 (4.26%) 
Weight decreased * 1  4/21 (19.05%)  12/47 (25.53%) 
Metabolism and nutrition disorders     
Anorexia * 1  8/21 (38.10%)  14/47 (29.79%) 
Dehydration * 1  4/21 (19.05%)  5/47 (10.64%) 
Hyperglycemia NOS * 1  6/21 (28.57%)  11/47 (23.40%) 
Hyperkalemia * 1  2/21 (9.52%)  3/47 (6.38%) 
Hypoalbuminemia * 1  5/21 (23.81%)  7/47 (14.89%) 
Hypocalcemia * 1  4/21 (19.05%)  10/47 (21.28%) 
Hypokalemia * 1  1/21 (4.76%)  7/47 (14.89%) 
Hyponatremia * 1  4/21 (19.05%)  15/47 (31.91%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/21 (9.52%)  7/47 (14.89%) 
Bone pain * 1  1/21 (4.76%)  3/47 (6.38%) 
Muscle weakness NOS * 1  0/21 (0.00%)  3/47 (6.38%) 
Pain in extremity * 1  1/21 (4.76%)  3/47 (6.38%) 
Nervous system disorders     
Dizziness * 1  1/21 (4.76%)  6/47 (12.77%) 
Dysgeusia * 1  1/21 (4.76%)  5/47 (10.64%) 
Headache * 1  0/21 (0.00%)  3/47 (6.38%) 
Peripheral motor neuropathy * 1  0/21 (0.00%)  3/47 (6.38%) 
Peripheral sensory neuropathy * 1  1/21 (4.76%)  8/47 (17.02%) 
Psychiatric disorders     
Anxiety * 1  2/21 (9.52%)  2/47 (4.26%) 
Insomnia * 1  4/21 (19.05%)  1/47 (2.13%) 
Renal and urinary disorders     
Bladder pain * 1  3/21 (14.29%)  9/47 (19.15%) 
Bladder spasm * 1  1/21 (4.76%)  6/47 (12.77%) 
Bladder stenosis * 1  2/21 (9.52%)  0/47 (0.00%) 
Cystitis NOS * 1  12/21 (57.14%)  17/47 (36.17%) 
Pollakiuria * 1  12/21 (57.14%)  24/47 (51.06%) 
Proteinuria * 1  2/21 (9.52%)  0/47 (0.00%) 
Renal/genitourinary - Other * 1  3/21 (14.29%)  2/47 (4.26%) 
Ureteric obstruction * 1  1/21 (4.76%)  4/47 (8.51%) 
Urethral pain * 1  0/21 (0.00%)  4/47 (8.51%) 
Urinary bladder hemorrhage * 1  4/21 (19.05%)  9/47 (19.15%) 
Urinary incontinence * 1  3/21 (14.29%)  6/47 (12.77%) 
Urinary retention * 1  2/21 (9.52%)  4/47 (8.51%) 
Reproductive system and breast disorders     
Pelvic pain NOS * 1  1/21 (4.76%)  3/47 (6.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/21 (9.52%)  10/47 (21.28%) 
Dyspnea * 1  3/21 (14.29%)  8/47 (17.02%) 
Hypoxia * 1  0/21 (0.00%)  3/47 (6.38%) 
Rhinitis allergic NOS * 1  0/21 (0.00%)  3/47 (6.38%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/21 (0.00%)  7/47 (14.89%) 
Dermatitis exfoliative NOS * 1  1/21 (4.76%)  4/47 (8.51%) 
Vascular disorders     
Hypertension NOS * 1  2/21 (9.52%)  1/47 (2.13%) 
Hypotension NOS * 1  2/21 (9.52%)  5/47 (10.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Accrual of patients with her2/neu overexpression stopped early due to unmet targeted accrual goals, with 22 subject accrued out of 40 planned.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00238420    
Other Study ID Numbers: NCI-2009-00730
NCI-2009-00730 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RTOG-0524
CDR0000440988
RTOG 0524 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0524 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: October 12, 2005
First Posted: October 13, 2005
Results First Submitted: December 10, 2015
Results First Posted: May 23, 2016
Last Update Posted: July 19, 2022